MedPath

Voclosporin

Generic Name
Voclosporin
Brand Names
Lupkynis
Drug Type
Small Molecule
Chemical Formula
C63H111N11O12
CAS Number
515814-01-4
Unique Ingredient Identifier
2PN063X6B1
Background

Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.

Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN. This cyclosporine A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN. Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.

In July 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended voclosporin be granted marketing authorization for use in combination with mycophenolate mofetil for the treatment of adult patients with active lupus nephritis.

Indication

联合免疫抑制疗法治疗成人活动性狼疮肾炎(LN)。

Associated Conditions
Lupus Nephritis
Associated Therapies
-

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Phase 1
Completed
Conditions
Drug-drug Interaction
Interventions
First Posted Date
2022-04-01
Last Posted Date
2022-04-20
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
24
Registration Number
NCT05306379
Locations
🇺🇸

Labcorp Clinical Research Unit, Dallas, Texas, United States

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

Phase 2
Recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2022-04-01
Last Posted Date
2024-01-19
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
120
Registration Number
NCT05306873
Locations
🇺🇸

UCLA Medical Center: Division of Rheumatology, Los Angeles, California, United States

🇺🇸

Yale University School of Medicine: Rheumatology, Allergy & Immunology, New Haven, Connecticut, United States

🇺🇸

Emory University School of Medicine: Division of Rheumatology, Atlanta, Georgia, United States

and more 8 locations

Voclosporin in Adolescents With Lupus Nephritis

Phase 3
Recruiting
Conditions
Adolescent Lupus Nephritis
Interventions
Drug: Placebo Oral Capsule
Drug: Voclosporin
First Posted Date
2022-03-21
Last Posted Date
2023-10-23
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
40
Registration Number
NCT05288855
Locations
🇺🇸

UNC-Chapel Hill, Chapel Hill, North Carolina, United States

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

Phase 2
Completed
Conditions
Kidney Transplant Infection
Covid19
Interventions
First Posted Date
2021-01-08
Last Posted Date
2024-10-17
Lead Sponsor
Leiden University Medical Center
Target Recruit Count
20
Registration Number
NCT04701528
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

Phase 2
Terminated
Conditions
Focal Segmental Glomerulosclerosis
Interventions
First Posted Date
2018-07-26
Last Posted Date
2021-09-16
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
5
Registration Number
NCT03598036
Locations
🇩🇴

FSGS Investigative Center, Santo Domingo, Dominican Republic

🇺🇸

FSGS Investigative Site, Salt Lake City, Utah, United States

🇩🇴

FSGS Investigative Centre, Santiago De Los Caballeros, Dominican Republic

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Phase 3
Completed
Conditions
Lupus Nephritis
Interventions
Drug: Placebo Oral Capsule
Drug: Voclosporin
First Posted Date
2018-07-24
Last Posted Date
2022-12-14
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
216
Registration Number
NCT03597464
Locations
🇺🇸

AURORA Investigative Center, Oklahoma City, Oklahoma, United States

Aurinia Renal Response in Active Lupus With Voclosporin

Phase 3
Completed
Conditions
Lupus Nephritis
Interventions
Drug: Voclosporin
Drug: Placebo Oral Capsule
First Posted Date
2017-01-16
Last Posted Date
2023-03-27
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
358
Registration Number
NCT03021499
Locations
🇻🇳

AURORA Investigative Center, Ho Chi Minh City, Vietnam

🇧🇾

AURORA Investigative Cener, Minsk, Belarus

🇺🇸

AURORA, Richmond, Virginia, United States

Voclosporin in Healthy Japanese Volunteers

Phase 1
Completed
Conditions
Volunteers
Interventions
First Posted Date
2016-10-31
Last Posted Date
2018-01-17
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
40
Registration Number
NCT02949999
Locations
🇵🇭

MAD VCS Site, Dasmarinas City, Cavite, Philippines

Aurinia Early Urinary Protein Reduction Predicts Response

Phase 2
Completed
Conditions
Lupus Nephritis
Interventions
First Posted Date
2016-10-31
Last Posted Date
2021-03-19
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Target Recruit Count
10
Registration Number
NCT02949973
Locations
🇲🇾

AURION Site, Kuala Lumpur, Malaysia

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

Phase 3
Withdrawn
Conditions
Renal Transplantation
Interventions
First Posted Date
2012-04-27
Last Posted Date
2014-01-20
Lead Sponsor
Aurinia Pharmaceuticals Inc.
Registration Number
NCT01586845
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